Breast Feeding Clinical Trial
Official title:
Effect of First Oral Feeding by the Mother on Preterm Infants' Feeding Performance and Physiological Symptoms
The goal of this clinical trial is to evaluate the effect of breastfeeding on the infant's test weight and physiological characteristics (oxygen saturation and heart rate) in preterm infants in the Neonatal Intensive Care Unit during the transition to oral feeding. The main question it aims to answer are: • Is there a difference in test weight and physiological parameters between the infants in whom the first oral feeding was performed by the mother and the infants in whom the first oral feeding was performed by the intensive care unit nurse with a bottle? Researchers will compare the breastfed group with the bottle-fed group to see if there are differences in test weight and physiological parameters.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 32 Weeks to 39 Weeks |
Eligibility | Inclusion Criteria: - Gestation week at birth determined according to the mother's last menstrual date is 26-31+6 weeks, - Postmenstrual week at the time of the study was 32-39+6 weeks, - Having a body weight of 1500 grams or more at the time of inclusion in the study, - Suggested by the physician to switch to oral nutrition and switched from enteral nutrition to oral nutrition for the first time, - Breastfed, - Preterm infants whose parents' consent was obtained for inclusion in the study and whose parents signed the informed consent form Exclusion Criteria: - Receiving oxygen, - Craniofacial anomalies such as cleft palate, cleft lip, facial muscle paralysis, - Preterm infants with any gastrointestinal, neurological and genetic disease (necrotizing enterocolitis, third and fourth level intracranial hemorrhage, periventricular leukomalacia, hydrocephalus, down syndrome, omphalocele, non-gastrodeia, short bowel syndrome and other diseases) |
Country | Name | City | State |
---|---|---|---|
Turkey | IstanbulUC | Avcilar | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
Chen CH, Wang TM, Chang HM, Chi CS. The effect of breast- and bottle-feeding on oxygen saturation and body temperature in preterm infants. J Hum Lact. 2000 Feb;16(1):21-7. doi: 10.1177/089033440001600105. — View Citation
Fontana C, Menis C, Pesenti N, Passera S, Liotto N, Mosca F, Roggero P, Fumagalli M. Effects of early intervention on feeding behavior in preterm infants: A randomized controlled trial. Early Hum Dev. 2018 Jun;121:15-20. doi: 10.1016/j.earlhumdev.2018.04. — View Citation
Gianni ML, Sannino P, Bezze E, Comito C, Plevani L, Roggero P, Agosti M, Mosca F. Does parental involvement affect the development of feeding skills in preterm infants? A prospective study. Early Hum Dev. 2016 Dec;103:123-128. doi: 10.1016/j.earlhumdev.20 — View Citation
Girgin BA, Gozen D, Karatekin G. Effects of two different feeding positions on physiological characteristics and feeding performance of preterm infants: A randomized controlled trial. J Spec Pediatr Nurs. 2018 Apr;23(2):e12214. doi: 10.1111/jspn.12214. Ep — View Citation
Goldfield EC, Richardson MJ, Lee KG, Margetts S. Coordination of sucking, swallowing, and breathing and oxygen saturation during early infant breast-feeding and bottle-feeding. Pediatr Res. 2006 Oct;60(4):450-5. doi: 10.1203/01.pdr.0000238378.24238.9d. Ep — View Citation
Moral A, Bolibar I, Seguranyes G, Ustrell JM, Sebastia G, Martinez-Barba C, Rios J. Mechanics of sucking: comparison between bottle feeding and breastfeeding. BMC Pediatr. 2010 Feb 11;10:6. doi: 10.1186/1471-2431-10-6. — View Citation
Rocha NM, Martinez FE, Jorge SM. Cup or bottle for preterm infants: effects on oxygen saturation, weight gain, and breastfeeding. J Hum Lact. 2002 May;18(2):132-8. doi: 10.1177/089033440201800204. — View Citation
Settle M, Francis K. Does the Infant-Driven Feeding Method Positively Impact Preterm Infant Feeding Outcomes? Adv Neonatal Care. 2019 Feb;19(1):51-55. doi: 10.1097/ANC.0000000000000577. — View Citation
Stevens EE, Gazza E, Pickler R. Parental experience learning to feed their preterm infants. Adv Neonatal Care. 2014 Oct;14(5):354-61. doi: 10.1097/ANC.0000000000000105. — View Citation
Thoyre SM, Pados BF, Shaker CS, Fuller K, Park J. Psychometric Properties of the Early Feeding Skills Assessment Tool. Adv Neonatal Care. 2018 Oct;18(5):E13-E23. doi: 10.1097/ANC.0000000000000537. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | preterm infant's weight gain | It is to determine the weight gain by weighing the preterm infant with the same diaper before and after oral feeding. | 30 minutes before oral feeding and 30 minutes after oral feeding is complete | |
Secondary | Oxygen saturation | Oxygen saturation = 90% during and just after oral feeding | 30 minutes | |
Secondary | Heart rate | Heart rate 120-160/min during and just after oral feeding | 30 minutes |
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